We are hiring a experienced CMC Compliance Expert to work on a fully remote basis within the US!

Key Functions include:

* Experienced in authoring of assessment reports

* Reviewing of quality documents (e.g. reformulation studies, process validations, particle size method implementation and specification etc)

* Serve as the CMC Product Lead for assigned products

* Lead development and execution of global product and project regulatory strategy(ies) by ensuring robust assessment of CMC changes

* Manage execution / authoring of CMC documentation

Ideal candidate would have:

* Marketing authorization experience

* Project Management experience

* 8-12 years of experienced in Pharmaceutical Regulatory Industry/ CMC

(Please note that candidate's quality will be reviewed on an overall basis)

Looking forward to hearing from you soon!